IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

K052623 · Medtronic Navigation, Inc. · HAW · Mar 2, 2006 · Neurology

Device Facts

• Record ID: K052623
• Device Name: IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
• Applicant: Medtronic Navigation, Inc.
• Product Code: HAW · Neurology
• Decision Date: Mar 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to: Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Placement of Iliosacral Screws Femoral Revision Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

Device Story

Imageless Hip Module for StealthStation® System enables stereotactic navigation without preoperative/intraoperative imaging. Device uses digitized anatomical landmarks to establish stereotactic coordinates; provides real-time tracking of surgical instruments and implants. Used in OR by surgeons for orthopedic procedures including total hip replacement, tumor resection, and pelvic fracture repair. System transforms digitized landmark inputs into spatial coordinates; displays instrument/implant position relative to anatomy on workstation screen. Assists surgeons in precise positioning; reduces reliance on intraoperative imaging; improves accuracy of implant placement.

Clinical Evidence

Bench testing only. Accuracy testing performed to validate the imageless coordinate establishment mechanism against the predicate system.

Technological Characteristics

Stereotaxic instrument; utilizes digitized anatomical landmarks for coordinate registration; software-based navigation module for StealthStation® platform; provides real-time spatial tracking of surgical instruments.

Indications for Use

Indicated for patients undergoing orthopedic procedures requiring stereotactic navigation, including total hip replacement (primary/revision), tumor resection, bone/joint reconstruction, iliosacral screw placement, femoral revision, and pelvic/acetabular fracture repair.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Hip Module for the StealthStation® System (K021980)

Submission Summary (Full Text)

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K052693

# Summary of Safety and Effectiveness Imageless Hip Module for the StealthStation® System

#### l. Manufacturer

Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: [phone] Fax Number: [phone]

1441 2 2006

### 11. Contact

Tina Dreiling Associate Requlatory Affairs Specialist Medtronic Navigation, Inc.

### lll. Product Name / Classification

Common Name: Stereotaxic instrument Classification Name: Instrument, Stereotaxic Trade Name: Imageless Hip Module for the StealthStation® System Stereotaxic instrument - Class II as described in 21 CFR § 882 4560 Product Code: HAW

### IV. Date Summary Submitted September 22, 2005

### V. Description of Device Modification

The Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a preoperative or intra-operative images.

### VI. Substantial Equivalence

The Imageless Hip Module for the StealthStation® System is substantially equivalent to the Hip Module for the StealthStation® System (K021980).

The only difference between the Hip Module for the StealthStation® System and the Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative images. In addition, the substantial equivalence for this application is established with the accuracy testing provided in this filing. As required by risk analysis, all verification and validation activities performed by designated individuals and the results demonstrated substantial equivalence.

### VII. Indications for Use

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Placement of Iliosacral Screws Femoral Revision Stabilization and Repair of Pelvic Fractures (Including But Not Limited to Acetabular Fractures)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of a stylized human figure. The figure is composed of three overlapping profiles, representing the department's focus on health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 2

Medtronic Navigation, Inc. c/o Ms. Tina Dreiling Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K052623

Trade/Device Name: Imageless Hip Module for the StealthStation® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 2, 2006 Received: February 3, 2006

Dear Ms. Dreiling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. IDrug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and lisung (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Dreiling

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
elmpe

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K052623

Device Name: Imageless Hip Module for the StealthStation® System

Indications for Use:

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative. and Neurological Devices

K052623 510(k) Number ...